NiCore Nitinol GuidewireRecalls & reported problems across all models
C. R. Bard, Inc. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 281
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls
- 0
We found 5 models of NiCore Nitinol Guidewire by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 281 adverse event reports in the FDA's MAUDE database, received between Sep 26, 2017 and Aug 4, 2026 — classified as 12 injuries, 269 malfunctions.
The most frequently reported specific device problem is “Flaked” (140 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported NiCore Nitinol Guidewire problems
Device problems
- Flaked140
- Material Fragmentation47
- Material Protrusion/Extrusion33
- Improper Chemical Reaction22
- Material Twisted/Bent16
- Difficult to Insert7
- Difficult to Advance6
- Accessory Incompatible5
Patient problems
- No Clinical Signs, Symptoms or Conditions222
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available26
- No Patient Involvement17
- No Known Impact Or Consequence To Patient13
- Exposure to Body Fluids11
- No Consequences Or Impact To Patient5
- Foreign Body In Patient3
- Perforation2
NiCore Nitinol Guidewire models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- NiCore Nitinol Guidewire 150NSS35STYLET FOR CATHETER, GASTRO-UROLOGY229 reports
- NiCore Nitinol Guidewire 150NFS35STYLET FOR CATHETER, GASTRO-UROLOGY30 reports
- NiCore Nitinol Guidewire 150NSA35STYLET FOR CATHETER, GASTRO-UROLOGY16 reports
- NiCore Nitinol Guidewire 150NFA35STYLET FOR CATHETER, GASTRO-UROLOGY5 reports
- NiCore Nitinol Guidewire 150NFA38STYLET FOR CATHETER, GASTRO-UROLOGY1 report
Recent NiCore Nitinol Guidewire adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 4, 2026Flaked
It was reported that during use on (b)(6) 2025, the patient underwent transurethral ureteroscopy with holmium laser lithotripsy under lumbar anesthesia for ureteral stones. Postoperatively, a hydrophilic guidewire (Bard guidewire) was inserted into the left ureter to guide the ureteroscope into the left ureter. After removing the hydrophilic guidewire, holmium laser lithotripsy was performed. After lithotripsy was completed, a hydrophilic guidewire was reinserted into the left ureter. During use, it was discovered that the hydrophilic coating on the surface of the guidewire had peeled off for no apparent reason, with some of the material falling into the ureter. The guidewire was therefore removed, and the detached hydrophilic material was retrieved piece by piece using stone retrieval forceps. The scope was reinserted, the hydrophilic guidewire was left in place, and F6 double J tubing was placed along the guidewire.
Patient problems: Foreign Body In Patient
MAUDE report 50136360 ↗MalfunctionJun 26, 2026Flaked
IT WAS REPORTED THAT, THE PHYSICIAN OPENED THE GUIDEWIRE PACKAGING, REMOVED THE PROTECTIVE CAP FROM THE GUIDEWIRE TIP, AND DISCOVERED THAT THE COATING ON THE TIP HAD PEELED OFF, RENDERING THE GUIDEWIRE UNUSABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25643266 ↗MalfunctionJun 5, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING USE THE GUIDEWIRE HAD HAIR AT THE FRONT END.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25410445 ↗MalfunctionMay 6, 2026Flaked
IT WAS REPORTED THAT ON (B)(6) 2026, WHEN THE DOCTOR PLANNED TO PERFORM A RADICAL NEPHROURETERECTOMY ON THE PATIENT, THE USE OF THE GUIDEWIRE REVEALED THAT THE INTERFACE SHOWED THE COATING PEELING OFF. THE GUIDEWIRE WAS THEN REPLACED WITH A NEW ONE TO COMPLETE THE SURGERY, WHICH DID NOT AFFECT THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25096386 ↗MalfunctionApr 3, 2026Flaked; Material Protrusion/Extrusion
IT WAS REPORTED THAT DURING THE PROCEDURE THE GUIDEWIRE FACED A MALFUNCTION WHILE PLACING THE GUIDEWIRE ACCORDING TO STANDARD OPERATING PROCEDURES. UPON WITHDRAWAL OF THE GUIDEWIRE, PEELING OF THE GUIDEWIRE SHEATH WAS OBSERVED. THE CLINICAL TEAM COMMUNICATED WITH THE SALES REPRESENTATIVE, STATING THAT THE PRODUCT HAD A QUALITY ISSUE AND NEEDED TO BE SENT TO THE MANUFACTURER FOR TESTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24781659 ↗MalfunctionMar 26, 2026Flaked
IT WAS REPORTED THAT DURING USE THE GUIDEWIRE COATING WRINKLES ON THE HEAD END OF THE CONSUMABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24708529 ↗MalfunctionMar 20, 2026Flaked
IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING URETEROSCOPIC LITHOTRIPSY WITH A FLEXIBLE URETEROSCOPE, USING A BARD GUIDEWIRE 150NSS35. THE GUIDEWIRE COATING HAD BEEN ACTIVATED, BUT DURING THE PROCEDURE, INTRAOPERATIVELY THE GUIDEWIRE COATING WAS FOUND TO BE PEELING OFF AND WAS VERY ASTRINGENT, WITH FAILURE TO ADVANCE THE BARD URETERAL STENT (B)(6) PROPERLY, REPLACED WITH A NEW GUIDEWIRE, AND THE STENT WAS SUCCESSFULLY PLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24650668 ↗MalfunctionMar 18, 2026Material Protrusion/Extrusion
IT WAS REPORTED THAT DURING A URETEROSCOPIC LASER LITHOTRIPSY PROCEDURE, SALINE WAS INJECTED INTO THE GUIDEWIRE COIL TO ACTIVATE IT. DURING USE, IT WAS DISCOVERED THAT THE GUIDEWIRE SHEATH HAD BURRS AND SUBSEQUENTLY DETACHED; AFTER REPLACEMENT, THE PROCEDURE PROCEEDED SMOOTHLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24631556 ↗MalfunctionMar 13, 2026Flaked
IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT UNDERWENT FLEXIBLE URETEROSCOPY LITHOTRIPSY AND STONE REMOVAL FOR RENAL CALCULI. AFTER INITIAL PLACEMENT OF A GUIDEWIRE AND INSERTION OF A SINGLE-USE URETERAL SHEATH, THE GUIDEWIRE PROVED DIFFICULT TO EXTRACT. UPON REMOVAL, THE GUIDEWIRE SURFACE COATING WAS OBSERVED TO BE PEELED OFF REFER TO ACTUAL SAMPLE AND IMAGE. FOLLOWING CLINICAL ASSESSMENT, A NEW ULTRA-SMOOTH GUIDEWIRE WAS SELECTED, ENABLING SUCCESSFUL COMPLETION OF SUBSEQUENT PROCEDURES. THE SURGERY CONCLUDED WITHOUT COMPLICATIONS. ALTHOUGH SURGICAL AND ANESTHESIA TIMES WERE EXTENDED, NO OTHER ADVERSE EFFECTS OCCURRED. THAT HOSPITAL ROUTINELY USES ULTRA SMOOTH GUIDEWIRES, AND SUCH COATING DETACHMENT WAS INFREQUENT. PATIENT PROCEDURE TIME WAS EXTENDED NO OTHER IMPACTS. A NEW ULTRA-SLIDE GUIDEWIRE WAS SELECTED, AND SUBSEQUENT PROCEDURES WERE COMPLETED SUCCESSFULLY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24595767 ↗MalfunctionJan 9, 2026Nonstandard Device
IT WAS REPORTED THAT A PROFESSOR AT THE THIRD AFFILIATED HOSPITAL OF SUN YAT-SEN UNIVERSITY WAS SCHEDULED TO PERFORM A STONE REMOVAL SURGERY ON (B)(6) 2025 BUT FOUND THAT THE TIP OF THE GUIDEWIRE WAS DAMAGED WHEN OPENING THE GUIDEWIRE PACKAGING BEFORE THE OPERATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24030184 ↗MalfunctionDec 29, 2025Flaked; Flaked
IT WAS REPORTED THAT, UPON UNPACKING THE GUIDEWIRE COATING WAS FOUND DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23914197 ↗MalfunctionDec 23, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT DURING THE PROCEDURE, THE GUIDEWIRE EXHIBITED SEVERE PEELING AND BURRING. AFTER REPLACING THE GUIDEWIRE, THE SURGERY WAS COMPLETED. THE PATIENT HAS BEEN EXPOSED TO HARMFUL SUBSTANCES, BLOOD OR BODY FLUIDS.
Patient problems: Exposure to Body Fluids
MAUDE report 23882704 ↗MalfunctionDec 15, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT, THE FRONT SECTION OF THE GUIDEWIRE WAS ROUGH AND PEELING, RENDERING IT UNUSABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23810490 ↗MalfunctionDec 12, 2025Flaked; Flaked
IT WAS REPORTED THAT DURING THE PROCEDURE, THE GUIDEWIRE EXHIBITED SEVERE PEELING AND BURRING. AFTER REPLACING THE GUIDEWIRE, THE SURGERY WAS COMPLETED. THE PATIENT HAS BEEN EXPOSED TO HARMFUL SUBSTANCES, BLOOD OR BODY FLUIDS.
Patient problems: Exposure to Body Fluids
MAUDE report 23796763 ↗MalfunctionDec 10, 2025Flaked; Flaked
WAS REPORTED THAT, THE FRONT SECTION OF THE GUIDEWIRE WAS ROUGH AND PEELING, RENDERING IT UNUSABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23772611 ↗
Other C. R. Bard, Inc. products
- Bardex I.C. Foley Catheter26 models · 3,607 reports
- Bardex Lubricath Foley Catheter38 models · 1,670 reports · 1 recall
- Bardex Lubri-Sil I.C. All-Silicone Foley Catheter26 models · 1,518 reports
- Magic3 Coude Intermittent Catheter with Sure-Grip Sleeve5 models · 1,466 reports
- Magic3 Intermittent Catheter with Sure-Grip Sleeve14 models · 1,310 reports
- Bardia Foley Catheter Silicone Coated19 models · 1,283 reports
- PureWick Female External Catheter5 models · 1,184 reports
- Bardex All-Silicone Foley Catheter12 models · 1,170 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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